SYNCHRON MULTI CALIBRATOR


Device Classification Name

calibrator, multi-analyte mixture

510(k) Number K110251
Device Name SYNCHRON MULTI CALIBRATOR
Applicant
BECKMAN COULTER, INC.
250 s. kraemer boulevard
mail stop e2 se08
brea, 
CA 
92821

Applicant Contact yvette lloyd
Correspondent
BECKMAN COULTER, INC.
250 s. kraemer boulevard
mail stop e2 se08
brea, 
CA 
92821

Correspodent Contact yvette lloyd
Regulation Number 862.1150
Classification Product Code
JIX  
Date Received 01/28/2011
Decision Date 05/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls